USP <661.2> Plastic Packaging Systems For Pharmaceutical Use

United States Pharmacopoeia (USP) constantly updates its chapters, testing standards, and validation procedures to keep up with the continuously evolving pharmaceutical, medical, and life sciences industries. Keeping on top of these updates is extremely important for manufacturers following USP guidelines.

BA Sciences is an ISO/IEC 17025-accredited, cGMP-approved, and FDA-registered pharmaceutical, biopharmaceutical, and medical device testing facility with over 30 years of experience providing extraordinarily accurate and high-quality analytical testing, qualification, and validation services to pharmaceutical, medical, and other health and life science industries.

As a customer-centric testing laboratory known for the speed of its response and technical prowess, BA Sciences can validate the physical and chemical properties of various pharmaceutical, health, and medical device products. The company has invaluable experience identifying bacterial toxins (endotoxins/ lipopolysaccharide) or other inhibitive elements that can affect the efficacy of your company’s manufacturing processes.

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Understanding USP <661.2>

USP <661> chapter “Plastic Packaging Systems and Their Materials of Construction” defines testing and qualification standards for the materials and thermoplastics used in manufacturing, assembling, and molding pharmaceutical packaging systems. Two new chapters were drafted to replace USP <661> in 2016, USP <661.1> and <661.2>, and both will be official on December 1, 2025.

The first chapter, USP <661.1> “Plastic Packaging Systems and Their Materials of Construction,” outlines testing procedures and parameters for each individual material/plastic used in manufacturing or molding packaging systems. In contrast, the second chapter, USP <661.2> “Plastic Packaging Systems For Pharmaceutical Use,” tests the finished packaged system or finished goods and any accompanying packaging material that comes in contact with the packaging system.

These chapters work hand-in-hand such that <661.1> is intended for analysis of the packaging material(s), and <661.2> is targeted for analysis of the final formed container. BA Sciences provides manufacturers with critical testing, validation, insight, and guidance to help them prepare.  While USP chapters <661.1> and <661.2> are not official until 2025, the USP and the industry are encouraging early adoption.  BA Sciences can help to devise an appropriate test strategy to will meet expectations and ensure compliance

Importance of USP <661.2> Compliance

The purpose of USP <661.2> is to guard against any anomalies that might occur once all materials are combined (molded) into a finished packaging system. While testing each resin material helps ensure the material’s quality, batch, and supplier, it doesn’t guarantee that the finished packaging system complies with established USP <661.2> testing.

The finished packaging system could include voids, inclusions, contamination, or other unidentifiable residues, such as additives, metals, and plastic, which could lead to biological reactivity. These issues can easily present themselves at any point during the manufacturing process. Even if the finished packaging system is void of any of these issues, any adjacent packaging material that encounters the packaging system could have these issues and, therefore, must also be tested.

Complete USP <661.2> Compliance Testing

BA Sciences remains ever vigilant of any modifications, revisions, or adjustments to USP chapter additions and revisions. Staying up to date on USP testing has positioned BA Sciences as a valued, trusted, and reliable testing partner for companies and manufacturers requiring polymer and thermoplastic material testing.

The company provides cutting-edge testing and engineering expertise with state-of-the-art equipment and validation processes. Here is a breakdown of the testing offered through BA Sciences regarding USP <661.2>:

Material Characterization Testing for USP <661.2>:

  • Physiochemical Tests
    • UV Absorbance
    • Acidity/Alkalinity
    • TOC
    • Appearance
    • Total Terephthaloyl moieties
    • Ethylene Glycol
  • Biological Reactivity
  • Spectral Transmission
  • Chemical Assessment

Simple, Effective, and Timely Solutions With BA Sciences

BA Sciences is a full-service, turnkey solutions provider for companies in the pharmaceutical, medical, life sciences, and health industries needing the expertise and insight that only comes from working with an ISO/IEC-17025:2017-certified testing laboratory.

BA Sciences’s knowledgeable and experienced team is committed to providing the most accurate testing data using precise testing processes, proven approaches, and state-of-the-art equipment.

To learn more about how BA Sciences can help support your company’s adoption of USP <661.2>, contact us now.

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